FDA Adverse Event
Malfunction
Summary report: N
BD Q-SYTE LUER ACCESS SPLIT SEPTUM
MDR report key: 2672493
·
Received July 20, 2012
Report
- Report Number
- 9610847-2012-00048
- Event Type
- Malfunction
- Date Received
- July 20, 2012
- Date of Event
- June 1, 2012
- Report Date
- July 19, 2012
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED ON (B)(4) 2012 AND SENT FOR DECONTAMINATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE BD Q-SYTE DEVICE HAD BEEN IN USE FOR APPROX 30 MINUTES AND HAD BEEN ACCESSED ONLY ONCE. MEDICATION LEAKAGE WAS OBSERVED FROM A CRACK IN THE BODY OF THE BD Q-SYTE DEVICE. THERE WAS NO HARM TO THE PT AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD Q-SYTE LUER ACCESS SPLIT SEPTUM | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 1060028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | PARENTERAL NUTRITION |